FDA and Novo Nordisk Warned of GLP-1 Telehealth Compounding Takedown. What’s Next?

On September 16, 2025, the FDA issued more than 55 warning letters to online sellers of compounded versions of glucagon-like peptide-1 (GLP-1) medications, the popular weight-loss injections marketed as semaglutide (Wegovy; Novo Nordisk) and tirzepatide (Zepbound; Eli Lilly). The FDA letters cited misleading direct-to-consumer advertising and marketing in a variety of forms.¹ At the time, the effort felt like “compliance theater,” not expected to change much behavior among GLP-1 compounders or marketers. For the most part, telehealth providers and compounding pharmacies have continued advertising and compounding products as patient-specific variants or copies of GLP-1 products.

On February 6, 2026, however, the FDA’s approach appeared to shift with an announcement that it would be taking steps to restrict GLP-1 active pharmaceutical ingredients (APIs) that continue to be used in non–FDA-approved compounded products, as well as to combat “misleading direct-to-consumer advertising and marketing.” Unequivocally, the FDA warned: “Entities engaged in the manufacture, distribution, or marketing of unapproved compounded GLP-1 products should be aware that failure to adequately address any violations may result in legal action without further notice, including, without limitation, seizure and injunction.” The FDA specifically named Hims & Hers, a popular and outspoken telehealth provider that advertises compounded GLP-1 products, in the announcement.²

On February 9, 2026, Novo Nordisk also escalated its enforcement actions by suing Hims & Hers “for infringing US Patent No. 8,129,343 with its compounded semaglutide products for the US market.” Novo Nordisk alleged that Hims & Hers has continued to “mass-compound injectable versions [of Novo Nordisk’s Wegovy (semaglutide)] made with inauthentic API” and further engaged in promotional campaigns suggesting its compounded semaglutide products compare to the safety and efficacy of Novo Nordisk’s Wegovy products, “putting patient health and well-being at risk.” Novo Nordisk further cited the FDA’s February 6 statement.³

Why the sudden ramp-up against GLP-1 compounders and marketers? One factor is that Novo Nordisk launched its newly FDA-approved once-daily tablet for semaglutide in January 2026. Some compounders had been mass-compounding semaglutide tablets in the absence of an FDA-approved alternative, but were expected to discontinue the practice once an FDA-approved version became available. Instead, Hims & Hers advertised a commercial launch of a compounded semaglutide tablet on February 5, 2026.⁴

These enforcement escalations follow the launch of TrumpRx on February 5, 2026, advertising access to lower-cost, FDA-approved GLP-1 options directly to patients. According to the TrumpRx website, for example, as of this writing, monthly costs for semaglutide tablets are now available at $149 to $299 (vs $1349), semaglutide injections at $199 to $349 (vs $1349), and tirzepatide injections at $299 to $449 (vs $1087).^5-7

How will the GLP-1 telehealth and compounding pharmacies respond? Some compounders will likely continue to assert that they are properly engaging as 503A pharmacies in patient-specific compounding pursuant to physician orders (503B outsourcing facility mass compounding was generally only permitted during shortages of the FDA-approved GLP-1 products). In 2018, the FDA published guidance to 503A pharmacies on what will be considered unauthorized compounding of a product that is “essentially a copy” of an FDA-approved product, with an exception available when the “prescriber documents on the prescription that the compounded drug product produces a significant difference for the identified individual patient.”⁸ Under the 2018 guidance, “FDA generally does not intend to question prescriber determinations that are documented in a prescription or notation.”⁸ To date, patient-specific GLP-1 compounding activities have often included adding supplemental ingredients to combat adverse effects of the GLP-1 products or customizing doses, with a significant percentage of prescriptions for customization written by telehealth prescribers.

Although not directly addressing the legitimacy of patient-specific compounding of GLP-1 products, the FDA has sent a cautionary sign to 503A pharmacies operating in this space. 503A pharmacies are state-licensed, leading many in the industry to believe the FDA has no oversight over them. But 503A pharmacies are also under FDA jurisdiction for compliance with requirements under the Federal Food, Drug, and Cosmetic Act (FD&C Act) for the compounded products they produce, noting that they are exempt from certain labeling requirements and current good manufacturing practices applicable to FDA-approved drugs and 503B compounded drugs.⁹

The FDA’s warning letter to 503A pharmacy Boothwyn Pharmacy, LLC, issued on January 16, 2026, but not published until February 10, identifies violations for the pharmacy’s GLP-1 and other compounded products concerning insanitary conditions and strength, quality, or purity noncompliance with the compounded products’ stated contents—all fair game under the FD&C Act. If such items are not addressed in a satisfactory or timely manner, the FDA has the authority to engage additional advisory action or, without further warning, initiate product recalls, product seizure, injunctions, and criminal actions, which could include civil monetary penalties, along with referral to states for additional action, including action related to the licenses of the pharmacy and pharmacists.¹⁰

Reading the writing on the wall and what it may signify, telemarketing companies, pharmacies, and other stakeholders selling GLP-1 products that are not FDA-approved should consider this change in tone and action from both the FDA and manufacturers in planning for the future, including in preparing to defend ongoing GLP-1 compounding or potentially realigning their compounding capacity for future markets.

REFERENCES

1. Siemer B, Rasmussen K. Beyond the headlines: FDA warning letters to GLP-1 compounders. Spencer Fane. September 26, 2025. Accessed March 24, 2026. https://www.spencerfane.com/insight/beyond-the-headlines-fda-warning-letters-to-glp-1-compounders/

2. FDA intends to take action against non-FDA-approved GLP-1 drugs. News release. FDA. February 6, 2026. Accessed March 24, 2026. https://www.fda.gov/news-events/press-announcements/fda-intends-take-action-against-non-fda-approved-glp-1-drugs

3. Novo Nordisk takes legal action against Hims & Hers to protect patients from unsafe, knockoff Wegovy and Ozempic. News release. Novo Nordisk. February 9, 2026. Accessed March 24, 2026. https://www.novonordisk.com/content/nncorp/global/en/news-and-media/news-and-ir-materials/news-details.html?id=916493

4. Primack C. More options, more support: new compounded semaglutide pill from Hims & Hers. Hims & Hers. February 5, 2026. Accessed March 24, 2026. https://news.hims.com/newsroom/more-options-more-support-new-compounded-semaglutide-pill-from-hims-hers

5. Fact sheet: President Donald J. Trump launches TrumpRx.gov to bring lower drug prices to American patients. The White House. February 5, 2026. Accessed March 24, 2026. https://www.whitehouse.gov/fact-sheets/2026/02/fact-sheet-president-donald-j-trump-launches-trumprx-gov-to-bring-lower-drug-prices-to-american-patients/

6. Wegovy pill. TrumpRx. Accessed March 24, 2026. https://trumprx.gov/p/wegovy-pill

7. Wegovy pen. TrumpRx. Accessed March 24, 2026. https://trumprx.gov/p/wegovy

8. Ozempic pen. TrumpRx. Accessed March 24, 2026. https://trumprx.gov/p/ozempic

9. US Department of Health and Human Services; FDA; Center for Drug Evaluation and Research; Office of Compliance. Compounded drug products that are essentially copies of a commercially available drug product under section 503A of the Federal Food, Drug, and Cosmetic Act. US Department of Health and Human Services. January 2018. Accessed March 24, 2026. https://www.fda.gov/files/drugs/published/Compounded-Drug-Products-That-Are-Essentially-Copies-of-a-Commercially-Available-Drug-Product-Under-Section-503A-of-the-Federal-Food--Drug--and-Cosmetic-Act-Guidance-for-Industry.pdf

10. Can the FDA inspect a 503a compounding pharmacy and facility? 503QM. May 9, 2022. Accessed March 24, 2026. https://www.503qm.com/can-the-fda-inspect-503a-compounding-pharmacies/

11. Warning letter to Boothwyn Pharmacy, LLC. FDA. January 16, 2026. Accessed March 24, 2026. https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/boothwyn-pharmacy-llc-717525-01162026